Investors in the pharma/biotech sector eagerly wait for
pipeline updates as they play an important role in deciding
whether or not to invest in a particular company. Pipelines are
of prime importance as far as pharma/biotech companies are
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Earlier this week,
) came out with disappointing news regarding its
Tafinlar-Mekinist combination for BRAF V600 E or K
mutation-positive unresectable or metastatic melanoma. The
company has withdrawn its Marketing Authorisation Application
(MAA) to the European Medicines Agency (EMA) for the combination.
Glaxo took this decision after the Committee for Medicinal
Products for Human Use (CHMP) indicated that the currently
available data of Tafinlar-Mekinist combination are insufficient
to form an opinion on its benefit-risk profile. The company plans
to resubmit the MAA once additional data from an ongoing phase
III program matures.
We remind investors that the Tafinlar-Mekinist combination was
approved by the U.S. Food and Drug Administration (FDA) for the
melanoma indication earlier this year. In the U.S., both Tafinlar
and Mekinist are available as monotherapy. In EU, Mekinist is
currently under regulatory review.
In the fourth quarter of 2013, Tafinlar (£11 million) and
Mekinist (£7 million) generated combined sales of £18 million.
Currently approved melanoma drugs include
) Zelboraf and
Bristol-Myers Squibb Company
Glaxo carries a Zacks Rank #4 (Sell).
Gilead Sciences Inc.
) is an example of a better ranked stock in the medical sector.
The stock carries a Zacks Rank #1 (Strong Buy).